What Is The Future Of Using Outcomes-Based Contracts Between Payers And Pharmaceutical Manufacturers To Gain Market Access For Advanced Oncologic And Biologic Agents?

Abstract

ObjectiveS: Niraparib was recently approved for maintenance treatment of recurrent ovarian cancer patients in response to platinum-based chemotherapy. In the clinical trial, niraparib dose was adjusted to manage adverse events, resulting in a lower average dose intensity (DI) compared to the starting dose of 300mg/day. The objective was to compare the average DI in the clinical trial and real-world settings for niraparib. MethOdS: The average DI in the clinical trial setting was obtained from the Phase 3 NOVA trial. The DI was calculated as the sum of daily doses actually consumed divided by total duration. The real-world DI was derived from data obtained through specialty pharmacies on dispensing and treatment discontinuation. The analysis was performed on patients with a minimum of 4 months (127 days) of follow up. For patients who discontinued treatment, treatment duration was the time between treatment start and treatment discontinuation. For patients who were still on therapy, treatment duration was time between treatment start and analysis date. Sensitivity analysis was conducted by setting the treatment duration for these patients based on either the analysis date or date of last dispense plus 30 days, whichever was later. ReSultS: Among the 367 patients treated with niraparib in the NOVA trial the mean (95% CI) DI was 194.98mg/day (±7.10) and the median was 195.12mg/day. Data was available in the real-world setting for 907 patients. In these patients, the mean (95% CI) DI was 202.43mg/day (±8.08) and median was 186.33mg/day. In the sensitivity analysis, the mean (95% CI) DI was 197.97mg/day (±7.99) and median was 183.67mg/day. CONCLUSIONS The DI in the real-world setting for niraparib is similar to that observed in the clinical trial. Since the cost of niraparib is proportional to dose administered, it is important to consider the actual DI in estimating the real-world cost of niraparib.